FDA.reportPublic FDA data

Neutral Topical

Manufacturer
AMD Medicom Inc.
Effective date
2020-12-09
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:02:44

Label at a glance#

ProductNeutral Topical
Active ingredientSODIUM FLUORIDE
Label structure6 sections

Dosage and administration

Indications: topical anti-caries preparation Directions: Following prophylaxis treatment, fill ¼ of tray with foam To dispense, shake bottle vigorously then invert applicator 180° downward to the bottom of the tray Insert tray in the patient’s mouth, have patient bite down lightly for 1 minute, up to a maximum of 4 minutes Remove tray and have patient expectorate excess Advise patient not to eat, drink or rinse fo...

Label contents#

Full prescribing information#

General Information

DESCRIPTION SECTION

AMD Medicom Inc.

DentiCare Pro-Foam

2% Neutral Topical Sodium Fluoride Foam (0.9% fluoride ion)

Mint

4.4 oz / 125 g

NDC 64778-0386-1

NPN 80009615

Rx Only in US

Item code 10038-M

I ndications and Directions

INDICATIONS & USAGE SECTION

Indications: topical anti-caries preparation

Directions:

  1. Following prophylaxis treatment, fill ¼ of tray with foam
  2. To dispense, shake bottle vigorously then invert applicator 180° downward to the bottom of the tray
  3. Insert tray in the patient’s mouth, have patient bite down lightly for 1 minute, up to a maximum of 4 minutes
  4. Remove tray and have patient expectorate excess

Advise patient not to eat, drink or rinse for 30 minutes after the treatment

Medicinal ingredients: Fluoride ions 0.9% w/w (from 2% w/w sodium fluoride)

Non-Medicinal Ingredients

INACTIVE INGREDIENT SECTION

water, sucralose, xylitol, betaine, pluronic, peppermint oil, spearmint oil

Warnings

WARNINGS AND PRECAUTIONS SECTION

KEEP OUT OF REACH OF CHILDREN. For professional use only

Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40°C or 104°F

Contents under pressure. Do not puncture or incinerate

Do not use if seal is broken

Contact Information

SPL UNCLASSIFIED SECTION


Made in USA for AMD Medicom Inc.
2555 Chemin de l’Aviation
Pointe-Claire, Montreal, Quebec, Canada
H9P 2Z2

Questions: 1-800-361-2862


www.medicom.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Panel 1Panel 1


Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64778-038664778-0386-1, 64778-0386-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b60e1223-b9dc-97d5-e053-2995a90a84e85fa5acb0-bf2d-cafe-e053-2a91aa0a09582020-12-09WarningsExact identifier
spl id: b60e1223-b9dc-97d5-e053-2995a90a84e8
spl set id: 5fa5acb0-bf2d-cafe-e053-2a91aa0a0958

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.